Diagnostic accuracy of Pluslife MiniDock MTB on tongue swabs in sputum scarce people with presumptive TB: a retrospective analysis

Diagnostic accuracy of Pluslife MiniDock MTB on tongue swabs in sputum scarce people with presumptive TB: a retrospective analysis | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Short Report Diagnostic accuracy of Pluslife MiniDock MTB on tongue swabs in sputum scarce people with presumptive TB: a retrospective analysis Loren Rockman, Shima Abdulgader, Stephanie Minnies, Daphne Naidoo, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6225528/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract MiniDock MTB (Pluslife, China) is a near-point-of-care swab-based tuberculosis test. Most data are from people who can expectorate sputum. In 86 sputum-scarce symptomatic adults, retrospective testing detected 53% (95% CI 28–77) of tuberculosis; halving the amount missed if only sputum tests were available. Infectious Diseases MiniDock MTB sputum-scarce tuberculosis tongue swabs Figures Figure 1 Main text Sputum is a bottleneck to expanding access to tuberculosis (TB) molecular testing ( 1 ), a public health priority. Promising swab-based tests, which can be done on tongue swabs or sputum-dipped swabs, are endorsed by the World Health Organization (WHO) ( 2 ). However, most data are from people who can expectorate sputum and are hence already testable using existing platforms. The biggest incremental benefit of tongue swabs (TSs) will be in people ordinarily unreachable by sputum tests. We showed TSs tested with Xpert MTB/RIF Ultra (Ultra; Cepheid, USA) could double the number of sputum-scarce ART-initiators diagnosed compared to if sputum alone was tested ( 3 ). Furthermore, a recent study in hospitalised sputum-scarce people in China found a in-house nucleic acid amplification test (NAAT) on TSs could detect 80% of TB that would otherwise require a bronchoscopy to diagnose ( 4 ). Lastly, in a multicounty evaluation of MiniDock MTB (Guangzhou Pluslife Biotech, China), the only near-point-of-care WHO-endorsed swab-based NAAT, TS diagnostic yield was non-inferior to sputum ( 5 ). We are unaware of MiniDock MTB evaluations exclusively in sputum-scarce people. This work was approved by the Health Research Ethics Committee of Stellenbosch University (M20/06/017, M21/10/022), City of Cape Town (9517) and Western Cape Department of Health (202203_035). Written informed consent was obtained. We identified flocked swabs (FLOQSwabs code 520C; Copan Italia S.p.A., Brescia, Italy) and paired raw induced sputum stored at -20°C from people ≥ 12 years with presumptive TB recruited in CAGE-TB (Clinicaltrials.gov NCT05317247) or SeroSelectTB (Clinicaltrials.gov NCT04752592) in Cape Town, South Africa from primary care facilities prior to treatment initiation. All people had been asked to expectorate sputum with coaching and had sputum induced if they could not expectorate at least one sputum ≥ 1 ml. Participants were classified as having TB using a microbiological reference standard (MRS) if, from a single Ultra and/or single MGIT960 culture, induced sputum was Ultra-positive for Mycobacterium tuberculosis complex. Participants not having TB had ≥ 1 negative result with no positive induced sputum Ultra or culture result. Participants missing a culture or Ultra result were, if other results negative, classified as not having TB. TSs from 86 people recruited between 04/07/2022-26/03/2025 were identified, of which 80 (93%) had paired induced sputum. After a median (interquartile range) storage duration of 10 (5–23) months, TSs were tested with MiniDock MTB with a minor protocol deviation to accommodate stored swabs’ shorter breakpoint (30 vs. 80 mm for Pluslife-supplied swabs; Supplementary text pg. 2 ) as collection was prior to MiniDock MTB availability. The rest of the procedure was per the manufacturer’s instructions ( 6 ), as was testing of induced sputum with the addition of homogenization using vortexing for 60 s prior to dipping of the swab. STARD guidelines were followed (Supplementary text pg. 4) ( 7 ). Diagnostic accuracy metrics were calculated using Excel (Microsoft, Redmond, USA) and compared using prtesti ( 8 ) and Fisher’s exact test ( 9 ) in STATA version 16.0 (StataCorp, Texas, USA). Diagnostic yield (DYT, diagnostic yield in those tested; DYD, diagnostic yield in those diagnosed) was calculated ( 10 ) and are further defined in Supplementary text pg. 2 . Twenty-two percent of people (19/86) had TB per the MRS and 20% (17/86) had previous TB. The median (IQR) age was 35 (26–46), 63% (54/86) were female, and 31% (27/86) were people living with HIV (PLHIV). TSs and induced sputum-dipped swabs had similar sensitivity [53% (95% confidence interval: 29–76) vs. 53% (28–77); p = 0.985] and specificity [97% (90–100) vs. 97% (89–100); p = 0.950] compared to the MRS (Fig. 1 , Table 1 ). Sensitivity and specificity for each sample type did not differ by previous TB or HIV statuses, however, for TSs, specificity was reduced in PLHIV compared to those without HIV [91% (71–99) vs. 100% (92–100); p = 0.040]. TSs and induced sputum-dipped swabs had similar DYTs (13%, 10/80) vs. (14%, 11/80) and DYDs (43%, 10/23) vs. (48%, 11/23). The proportion TS and induced sputum-dipped swab -positive by induced sputum Ultra semi-quantitation category are in Supplementary Table 1. Table 1 Diagnostic accuracy of MiniDock MTB on tongue swabs and induced sputum-dipped swabs compared to the MRS for the detection of TB stratified by HIV, and separately, previous TB status. Data is %, (95% CI), and n/N. Overall β (n = 86) HIV-negative (n = 59) HIV-positive (n = 27) Sensitivity Specificity Sensitivity Specificity Sensitivity Specificity Tongue swab 53 is(29, 76) 10/19 97 (90, 100) 65/67 50 (23, 77) 7/14 100 (92, 100) 45/45 60 (15, 95) 3/5 p = 0.701 * 91 (71, 99) 20/22 p = 0.040 * Induced sputum-dipped swab 53 (28, 77) 9/17 p = 0.985 € 97 (89, 100) 61/63 p = 0.950 € 54 (25, 81) 7/13 p = 0.842 € 95 (84, 99) 41/43 p = 0.143 € 50 (7, 93) 2/4 p = 0.640 € p = 0.720 * 100 (83, 100) 20/20 p = 0.167 € p = 0.327 * Overall β (n = 86) No previous TB (n = 69) Previous TB (n = 17) Tongue swab 53 is(29, 76) 10/19 97 (90, 100) 65/67 63 (35, 85) 10/16 96 (87, 100) 51/53 0 (0, 71) 0/3 p = 0.087 * 100 (77, 100) 14/14 p = 0.461 * Induced sputum-dipped swab 53 (28, 77) 9/17 p = 0.985 € 97 (89, 100) 61/63 p = 0.950 € 60 (32, 84) 9/15 p = 0.886 € 96 (86, 100) 47/49 p = 0.936 € 0 (0, 84) 0/2 p ≤ 0.999 € p = 0.206 * 100 (77, 100) 14/14 p ≤ 0.999 € p = 0.442 * Within row p-values: *HIV-negative vs. HIV-positive / No previous TB vs. previous TB Within column p-values: € tongue swab vs. induced sputum swab Abbreviations: CI, confidence interval; MRS, microbiological reference standard β Six people had no MiniDock MTB induced sputum swab result Two sputum Ultra error results were reported and upon repeat Ultra testing done, resolved to one being MTB detected and the other, MTB not detected Our key finding is TS testing using MiniDock MTB in people who - even in a well-resourced research environment - could not expectorate sputum would approximately halve the amount of sputum-scarce TB missed. In other words, TS sensitivity estimates reported here, which are lower than other reports ( 11 ) that included primarily sputum productive people with relatively advanced disease, are most appropriately compared to the typical programmatic scenario where sputum-scarce people are generally completely unable to access a rapid molecular test. Our findings also suggest sensitivity between TSs and induced sputum are similar, which make sputum induction harder to justify in programmatic care, unless perhaps if a more sensitive test (for example, culture) is applied. Notably, MiniDock MTB sensitivity in induced sputum was lower than a prior report ( 11 ) that used expectorated sputum, potentially reflecting biomass dilution due to saline. We also identified diminished specificity in PLHIV compared to people without HIV and this appeared independent on previous TB (a cause of false-positivity in sputum NAATs) ( 12 ), possibly reflecting oral mycobacterial carriage. Long term follow-up of such “false-positive” people are needed. Our study had strengths and limitations. To rapidly generate data submittable to a WHO call for data in 2025, we retrospectively tested samples and, for TSs, this necessitate a minor deviation from the instructions-for-use, however, this was done in consultation with the manufacturer. Prospective data from sputum-scarce people, which we are generating, is needed. In summary, our data suggest MiniDock MTB on TSs is a viable alternative to testing induced sputum, which is seldom available in programmatic conditions, and this can at least halve the amount of sputum-scarce TB missed. Declarations Declaration of interests The content hereof is the sole responsibility of the authors and does not necessarily represent the official views of the SAMRC. GT reports funding from the EDCTP2 programme supported by the EU (RIA2018D-2493, SeroSelectTB; RIA2020I-3305, CAGE-TB) and the National Institutes of Health (D43TW010350, U01AI152087, U54EB027049, and R01AI136894). This project is also supported by Global Health EDCTP3 and its members (101145817, 4-CAGE-TB). This research was funded in whole or in part by Science for Africa Foundation to the Developing Excellence in Leadership, Training and Science in Africa [Developing Excellence in Leadership and Genomics Training for Malaria Elimination and AntiMicrobial Resistance control in Africa (DELGEME Plus)] programme [Del-22-013] with support from Wellcome Trust and the UK Foreign, Commonwealth & Development Office and is part of the EDCPT2 programme supported by the European Union. Pluslife donated test kits used in the study. They did not, however, have a role in study design or result interpretation. Funding LR acknowledges funding from the SAMRC. The work reported herein was made possible through funding by the South African Medical Research Council through its Division of Research Capacity Development under the Bongani Mayosi National Health Scholars Programme from funding received from the Public Health Enhancement Fund / South African National Department of Health. Acknowledgements The authors thank the National Health Laboratory Services, Cape Town, South Africa, members of the Clinical Mycobacteriology & Epidemiology (CLIME) research group, and study participants. References Nathavitharana RR, Garcia-Basteiro AL, Ruhwald M, Cobelens F, Theron G (2022) Reimagining the status quo: How close are we to rapid sputum-free tuberculosis diagnostics for all? EBioMedicine. ;78 World Health Organization Near point-of-care nucleic acid amplification tests (NPOC- NAATs) as a new diagnostic class for diagnosis of TB using sputum and tongue swabs [cited 2026 March 3]. Available from: https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/diagnosis-treatment/npoc-tongue-swabs-and-sputum-pooling-for-tb/npoc-naats?utm_source=chatgpt.com Rockman L, Abdulgader S, Minnies S, Palmer Z, Naidoo CC, Naidoo D et al (2025) Oral washes and tongue swabs for Xpert MTB/RIF Ultra-based tuberculosis diagnosis in people with and without the ability to make sputum. Research Square. :rs. 3. rs-6225530 Wang Y, Li R, Cai L, Jin L, Cui J, Ma Z et al (2026) Accuracy of rapid quantitative PCR on tongue swabs for pulmonary tuberculosis in sputum-scarce patients: a prospective multicentre diagnostic study. Clin Infect Dis. :ciag071 Moe CA, Luswata RK, Barrameda AJ, Le H, Muzazu S, Crowder R et al (2026) Diagnostic yield of tongue swab-compared to sputum-based molecular testing for tuberculosis in four high-burden countries. Clin Infect Dis. :ciag077 Pluslife (2025) MiniDock MTB Instructions for Use Cohen JF, Korevaar DA, Altman DG, Bruns DE, Gatsonis CA, Hooft L et al (2016) STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ open ;6(11) StataCorp L prtest-Tests of proportions [cited 2023 Oct 22]. Available from: https://www.stata.com/manuals/rprtest.pdf McDonald JH (2014) Handbook of biological statistics Broger T, Marx FM, Theron G, Marais BJ, Nicol MP, Kerkhoff AD et al (2024) Diagnostic yield as an important metric for the evaluation of novel tuberculosis tests: rationale and guidance for future research. Lancet Global Health 12(7):e1184–e91 Steadman A, Kumar KM, Asege L, Kato-Maeda M, Mukwatamundu J, Shah K et al (2025) Diagnostic accuracy of swab-based molecular tests for tuberculosis using near-point-of-care platforms: a multi-country evaluation. EBioMedicine. ;121 Theron G, Venter R, Smith L, Esmail A, Randall P, Sood V et al (2018) False-positive Xpert MTB/RIF results in retested patients with previous tuberculosis: frequency, profile, and prospective clinical outcomes. J Clin Microbiol 56(3):01696–01617. 10.1128/jcm Additional Declarations The authors declare no competing interests. Supplementary Files BriefreportSupplementaryresults.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6225528","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Short Report","associatedPublications":[],"authors":[{"id":609527775,"identity":"fca7894f-8612-411c-b423-cbe9a31eab9f","order_by":0,"name":"Loren Rockman","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAu0lEQVRIiWNgGAWjYHACZhAhR7oWY9K1JDYQrd68vfmx0Y2aO+nzZ+QeYPhRw2DPT0izzJljxsk5x57lbriRl8DYc4yBWeIAAS0SEjnMh3PYDudukMgxYOBtYGBjIE7Lv8Pp8jNyDBj/NjDwyBOjJTm37XACw40cA2agLRIGBLXwHDM2zu07bLjhzBuDwzLHJAwMCWphb34snfPtsLx8e47hwzc1NvZyhLSgAKBiCVLUj4JRMApGwSjABQDRsjoDO4cNdQAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0002-7882-2157","institution":"Stellenbosch University","correspondingAuthor":true,"prefix":"","firstName":"Loren","middleName":"","lastName":"Rockman","suffix":""},{"id":609527776,"identity":"624cc3d7-6f2a-4e83-8e12-9f014b969111","order_by":1,"name":"Shima Abdulgader","email":"","orcid":"","institution":"Stellenbosch University","correspondingAuthor":false,"prefix":"","firstName":"Shima","middleName":"","lastName":"Abdulgader","suffix":""},{"id":609527777,"identity":"c53100ad-a1da-4f7e-82cb-dee96d8279cb","order_by":2,"name":"Stephanie Minnies","email":"","orcid":"","institution":"Stellenbosch University","correspondingAuthor":false,"prefix":"","firstName":"Stephanie","middleName":"","lastName":"Minnies","suffix":""},{"id":609527778,"identity":"5ebb31c6-52a4-4da8-83ab-bb4c27a39bb8","order_by":3,"name":"Daphne Naidoo","email":"","orcid":"","institution":"Stellenbosch University","correspondingAuthor":false,"prefix":"","firstName":"Daphne","middleName":"","lastName":"Naidoo","suffix":""},{"id":609527779,"identity":"bb04ac31-a6d5-470c-b9d0-d44ed2f05391","order_by":4,"name":"Arthur Chiwaya","email":"","orcid":"","institution":"Stellenbosch University","correspondingAuthor":false,"prefix":"","firstName":"Arthur","middleName":"","lastName":"Chiwaya","suffix":""},{"id":609527780,"identity":"c6624bd8-fe46-4257-88b0-717e33004dc6","order_by":5,"name":"Welile Nwamba","email":"","orcid":"","institution":"Stellenbosch University","correspondingAuthor":false,"prefix":"","firstName":"Welile","middleName":"","lastName":"Nwamba","suffix":""},{"id":609527781,"identity":"6b005d8b-bd37-4691-b553-28001d796c1c","order_by":6,"name":"Anna Okunola","email":"","orcid":"","institution":"Stellenbosch University","correspondingAuthor":false,"prefix":"","firstName":"Anna","middleName":"","lastName":"Okunola","suffix":""},{"id":609527782,"identity":"68625994-1fa0-48cd-abb7-5a815ef74ead","order_by":7,"name":"Grant Theron","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAyElEQVRIiWNgGAWjYFACHjApR4IONogWY9K1JDYQrUM+vvfg44qKO+nzZ+QeYPhRw2DPT0iz4TG+ZMMzZ57lbriRl8DYc4yBWeIAIS1tPGaSjW2HczdI5Bgw8DYwsDEQocX8J1BLuvyMHAPGvw0MPPKEtMiz8ZgxArUkMNzIMWAG2iJhQEiLAVuOsWTDmcOGG868MTgsc0zCwJCgLc1nDD82VByWl2/PMXz4psbGXo6gLcgKgGwJAupBtjQQVjMKRsEoGAUjHQAAUv47y4fMmMEAAAAASUVORK5CYII=","orcid":"","institution":"Stellenbosch University","correspondingAuthor":true,"prefix":"","firstName":"Grant","middleName":"","lastName":"Theron","suffix":""}],"badges":[],"createdAt":"2025-03-14 10:56:12","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-6225528/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6225528/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":105208372,"identity":"daee75f4-a104-4c2e-9c56-b2afa05719a9","added_by":"auto","created_at":"2026-03-23 13:13:46","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":142619,"visible":true,"origin":"","legend":"\u003cp\u003eForest plot of MiniDock MTB sensitivity and specificity on tongue and induced sputum-dipped swabs in sputum scarce people, overall and stratified by HIV. Performance was similar between the two sample types and across different groups, however reduced specificity was observed for tongue swabs in people living with HIV (PLHIV) compared to people without HIV (PWHIV).\u003c/p\u003e","description":"","filename":"Onlinefloatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-6225528/v1/309b95e9ae6c03e2e908fae7.png"},{"id":105208373,"identity":"a0123108-53be-40eb-93c4-41219431d8a9","added_by":"auto","created_at":"2026-03-23 13:13:51","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":780132,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6225528/v1/64bac680-953d-4615-a9f3-0cc5766db702.pdf"},{"id":105208371,"identity":"533ab57a-c4e2-4839-b320-5dfb1da9d91b","added_by":"auto","created_at":"2026-03-23 13:13:46","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":47059,"visible":true,"origin":"","legend":"","description":"","filename":"BriefreportSupplementaryresults.docx","url":"https://assets-eu.researchsquare.com/files/rs-6225528/v1/f81a43edb9d128de93cf3224.docx"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eDiagnostic accuracy of Pluslife MiniDock MTB on tongue swabs in sputum scarce people with presumptive TB: a retrospective analysis\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Main text","content":"\u003cp\u003eSputum is a bottleneck to expanding access to tuberculosis (TB) molecular testing (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e), a public health priority. Promising swab-based tests, which can be done on tongue swabs or sputum-dipped swabs, are endorsed by the World Health Organization (WHO) (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). However, most data are from people who can expectorate sputum and are hence already testable using existing platforms. The biggest incremental benefit of tongue swabs (TSs) will be in people ordinarily unreachable by sputum tests.\u003c/p\u003e \u003cp\u003eWe showed TSs tested with Xpert MTB/RIF Ultra (Ultra; Cepheid, USA) could double the number of sputum-scarce ART-initiators diagnosed compared to if sputum alone was tested (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Furthermore, a recent study in hospitalised sputum-scarce people in China found a in-house nucleic acid amplification test (NAAT) on TSs could detect 80% of TB that would otherwise require a bronchoscopy to diagnose (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Lastly, in a multicounty evaluation of MiniDock MTB (Guangzhou Pluslife Biotech, China), the only near-point-of-care WHO-endorsed swab-based NAAT, TS diagnostic yield was non-inferior to sputum (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). We are unaware of MiniDock MTB evaluations exclusively in sputum-scarce people.\u003c/p\u003e \u003cp\u003e This work was approved by the Health Research Ethics Committee of Stellenbosch University (M20/06/017, M21/10/022), City of Cape Town (9517) and Western Cape Department of Health (202203_035). Written informed consent was obtained. We identified flocked swabs (FLOQSwabs code 520C; Copan Italia S.p.A., Brescia, Italy) and paired raw induced sputum stored at -20\u0026deg;C from people\u0026thinsp;\u0026ge;\u0026thinsp;12 years with presumptive TB recruited in CAGE-TB (Clinicaltrials.gov NCT05317247) or SeroSelectTB (Clinicaltrials.gov NCT04752592) in Cape Town, South Africa from primary care facilities prior to treatment initiation. All people had been asked to expectorate sputum with coaching and had sputum induced if they could not expectorate at least one sputum\u0026thinsp;\u0026ge;\u0026thinsp;1 ml.\u003c/p\u003e \u003cp\u003eParticipants were classified as having TB using a microbiological reference standard (MRS) if, from a single Ultra and/or single MGIT960 culture, induced sputum was Ultra-positive for \u003cem\u003eMycobacterium tuberculosis\u003c/em\u003e complex. Participants not having TB had\u0026thinsp;\u0026ge;\u0026thinsp;1 negative result with no positive induced sputum Ultra or culture result. Participants missing a culture or Ultra result were, if other results negative, classified as not having TB.\u003c/p\u003e \u003cp\u003eTSs from 86 people recruited between 04/07/2022-26/03/2025 were identified, of which 80 (93%) had paired induced sputum. After a median (interquartile range) storage duration of 10 (5\u0026ndash;23) months, TSs were tested with MiniDock MTB with a minor protocol deviation to accommodate stored swabs\u0026rsquo; shorter breakpoint (30 vs. 80 mm for Pluslife-supplied swabs; \u003cb\u003eSupplementary text pg. 2\u003c/b\u003e) as collection was prior to MiniDock MTB availability. The rest of the procedure was per the manufacturer\u0026rsquo;s instructions (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e), as was testing of induced sputum with the addition of homogenization using vortexing for 60 s prior to dipping of the swab.\u003c/p\u003e \u003cp\u003eSTARD guidelines were followed \u003cb\u003e(Supplementary text pg. 4)\u003c/b\u003e (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Diagnostic accuracy metrics were calculated using Excel (Microsoft, Redmond, USA) and compared using prtesti (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) and Fisher\u0026rsquo;s exact test (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) in STATA version 16.0 (StataCorp, Texas, USA). Diagnostic yield (DYT, diagnostic yield in those tested; DYD, diagnostic yield in those diagnosed) was calculated (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) and are further defined in \u003cb\u003eSupplementary text pg. 2\u003c/b\u003e.\u003c/p\u003e \u003cp\u003eTwenty-two percent of people (19/86) had TB per the MRS and 20% (17/86) had previous TB. The median (IQR) age was 35 (26\u0026ndash;46), 63% (54/86) were female, and 31% (27/86) were people living with HIV (PLHIV).\u003c/p\u003e \u003cp\u003eTSs and induced sputum-dipped swabs had similar sensitivity [53% (95% confidence interval: 29\u0026ndash;76) vs. 53% (28\u0026ndash;77); p\u0026thinsp;=\u0026thinsp;0.985] and specificity [97% (90\u0026ndash;100) vs. 97% (89\u0026ndash;100); p\u0026thinsp;=\u0026thinsp;0.950] compared to the MRS (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Sensitivity and specificity for each sample type did not differ by previous TB or HIV statuses, however, for TSs, specificity was reduced in PLHIV compared to those without HIV [91% (71\u0026ndash;99) vs. 100% (92\u0026ndash;100); p\u0026thinsp;=\u0026thinsp;0.040]. TSs and induced sputum-dipped swabs had similar DYTs (13%, 10/80) vs. (14%, 11/80) and DYDs (43%, 10/23) vs. (48%, 11/23). The proportion TS and induced sputum-dipped swab -positive by induced sputum Ultra semi-quantitation category are in \u003cb\u003eSupplementary Table\u0026nbsp;1.\u003c/b\u003e\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDiagnostic accuracy of MiniDock MTB on tongue swabs and induced sputum-dipped swabs compared to the MRS for the detection of TB stratified by HIV, and separately, previous TB status. Data is %, (95% CI), and n/N.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eOverall\u003csup\u003eβ\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;86)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eHIV-negative\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;59)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003eHIV-positive\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;27)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSensitivity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSpecificity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSensitivity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSpecificity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSensitivity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eSpecificity\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTongue swab\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e53 is(29, 76)\u003c/p\u003e \u003cp\u003e10/19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e97 (90, 100)\u003c/p\u003e \u003cp\u003e65/67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e50 (23, 77)\u003c/p\u003e \u003cp\u003e7/14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100 (92, 100)\u003c/p\u003e \u003cp\u003e45/45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e60 (15, 95)\u003c/p\u003e \u003cp\u003e3/5\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.701\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e91 (71, 99)\u003c/p\u003e \u003cp\u003e20/22\u003c/p\u003e \u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.040\u003c/b\u003e\u003csup\u003e\u003cb\u003e*\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eInduced sputum-dipped swab\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e53 (28, 77)\u003c/p\u003e \u003cp\u003e9/17\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.985\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e97 (89, 100)\u003c/p\u003e \u003cp\u003e61/63\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.950\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e54 (25, 81)\u003c/p\u003e \u003cp\u003e7/13\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.842\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e95 (84, 99)\u003c/p\u003e \u003cp\u003e41/43\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.143\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e50 (7, 93)\u003c/p\u003e \u003cp\u003e2/4\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.640\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.720\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e100 (83, 100)\u003c/p\u003e \u003cp\u003e20/20\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.167\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.327\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e\u003cb\u003eOverall\u003c/b\u003e\u003csup\u003e\u003cb\u003eβ\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003e(n\u0026thinsp;=\u0026thinsp;86)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e\u003cb\u003eNo previous TB\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003e(n\u0026thinsp;=\u0026thinsp;69)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e\u003cb\u003ePrevious TB\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003e(n\u0026thinsp;=\u0026thinsp;17)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTongue swab\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e53 is(29, 76)\u003c/p\u003e \u003cp\u003e10/19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e97 (90, 100)\u003c/p\u003e \u003cp\u003e65/67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e63 (35, 85)\u003c/p\u003e \u003cp\u003e10/16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e96 (87, 100)\u003c/p\u003e \u003cp\u003e51/53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0, 71)\u003c/p\u003e \u003cp\u003e0/3\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.087\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e100 (77, 100)\u003c/p\u003e \u003cp\u003e14/14\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.461\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eInduced sputum-dipped swab\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e53 (28, 77)\u003c/p\u003e \u003cp\u003e9/17\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.985\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e97 (89, 100)\u003c/p\u003e \u003cp\u003e61/63\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.950\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e60 (32, 84)\u003c/p\u003e \u003cp\u003e9/15\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.886\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e96 (86, 100)\u003c/p\u003e \u003cp\u003e47/49\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.936\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0, 84)\u003c/p\u003e \u003cp\u003e0/2\u003c/p\u003e \u003cp\u003ep\u0026thinsp;\u0026le;\u0026thinsp;0.999\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.206\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e100 (77, 100)\u003c/p\u003e \u003cp\u003e14/14\u003c/p\u003e \u003cp\u003ep\u0026thinsp;\u0026le;\u0026thinsp;0.999\u003csup\u003e\u0026euro;\u003c/sup\u003e\u003c/p\u003e \u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.442\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eWithin row p-values: *HIV-negative vs. HIV-positive / No previous TB vs. previous TB\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eWithin column p-values: \u003csup\u003e\u0026euro;\u003c/sup\u003etongue swab vs. induced sputum swab\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eAbbreviations: CI, confidence interval; MRS, microbiological reference standard\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003e\u003csup\u003e\u003cb\u003eβ\u003c/b\u003e\u003c/sup\u003eSix people had no MiniDock MTB induced sputum swab result\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eTwo sputum Ultra error results were reported and upon repeat Ultra testing done, resolved to one being MTB detected and the other, MTB not detected\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eOur key finding is TS testing using MiniDock MTB in people who - even in a well-resourced research environment - could not expectorate sputum would approximately halve the amount of sputum-scarce TB missed. In other words, TS sensitivity estimates reported here, which are lower than other reports (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) that included primarily sputum productive people with relatively advanced disease, are most appropriately compared to the typical programmatic scenario where sputum-scarce people are generally completely unable to access a rapid molecular test.\u003c/p\u003e \u003cp\u003e Our findings also suggest sensitivity between TSs and induced sputum are similar, which make sputum induction harder to justify in programmatic care, unless perhaps if a more sensitive test (for example, culture) is applied. Notably, MiniDock MTB sensitivity in induced sputum was lower than a prior report (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) that used expectorated sputum, potentially reflecting biomass dilution due to saline. We also identified diminished specificity in PLHIV compared to people without HIV and this appeared independent on previous TB (a cause of false-positivity in sputum NAATs) (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e), possibly reflecting oral mycobacterial carriage. Long term follow-up of such \u0026ldquo;false-positive\u0026rdquo; people are needed.\u003c/p\u003e \u003cp\u003eOur study had strengths and limitations. To rapidly generate data submittable to a WHO call for data in 2025, we retrospectively tested samples and, for TSs, this necessitate a minor deviation from the instructions-for-use, however, this was done in consultation with the manufacturer. Prospective data from sputum-scarce people, which we are generating, is needed.\u003c/p\u003e \u003cp\u003eIn summary, our data suggest MiniDock MTB on TSs is a viable alternative to testing induced sputum, which is seldom available in programmatic conditions, and this can at least halve the amount of sputum-scarce TB missed.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eDeclaration of interests\u003c/h2\u003e \u003cp\u003eThe content hereof is the sole responsibility of the authors and does not necessarily represent the official views of the SAMRC. GT reports funding from the EDCTP2 programme supported by the EU (RIA2018D-2493, SeroSelectTB; RIA2020I-3305, CAGE-TB) and the National Institutes of Health (D43TW010350, U01AI152087, U54EB027049, and R01AI136894). This project is also supported by Global Health EDCTP3 and its members (101145817, 4-CAGE-TB). This research was funded in whole or in part by Science for Africa Foundation to the Developing Excellence in Leadership, Training and Science in Africa [Developing Excellence in Leadership and Genomics Training for Malaria Elimination and AntiMicrobial Resistance control in Africa (DELGEME Plus)] programme [Del-22-013] with support from Wellcome Trust and the UK Foreign, Commonwealth \u0026amp; Development Office and is part of the EDCPT2 programme supported by the European Union. Pluslife donated test kits used in the study. They did not, however, have a role in study design or result interpretation.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eLR acknowledges funding from the SAMRC. The work reported herein was made possible through funding by the South African Medical Research Council through its Division of Research Capacity Development under the Bongani Mayosi National Health Scholars Programme from funding received from the Public Health Enhancement Fund / South African National Department of Health.\u003c/p\u003e\u003ch2\u003eAcknowledgements\u003c/h2\u003e \u003cp\u003eThe authors thank the National Health Laboratory Services, Cape Town, South Africa, members of the Clinical Mycobacteriology \u0026amp; Epidemiology (CLIME) research group, and study participants.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eNathavitharana RR, Garcia-Basteiro AL, Ruhwald M, Cobelens F, Theron G (2022) Reimagining the status quo: How close are we to rapid sputum-free tuberculosis diagnostics for all? EBioMedicine. ;78\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWorld Health Organization Near point-of-care nucleic acid amplification tests (NPOC- NAATs) as a new diagnostic class for diagnosis of TB using sputum and tongue swabs [cited 2026 March 3]. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/diagnosis-treatment/npoc-tongue-swabs-and-sputum-pooling-for-tb/npoc-naats?utm_source=chatgpt.com\u003c/span\u003e\u003cspan address=\"https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/diagnosis-treatment/npoc-tongue-swabs-and-sputum-pooling-for-tb/npoc-naats?utm_source=chatgpt.com\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRockman L, Abdulgader S, Minnies S, Palmer Z, Naidoo CC, Naidoo D et al (2025) Oral washes and tongue swabs for Xpert MTB/RIF Ultra-based tuberculosis diagnosis in people with and without the ability to make sputum. Research Square. :rs. 3. rs-6225530\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang Y, Li R, Cai L, Jin L, Cui J, Ma Z et al (2026) Accuracy of rapid quantitative PCR on tongue swabs for pulmonary tuberculosis in sputum-scarce patients: a prospective multicentre diagnostic study. Clin Infect Dis. :ciag071\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoe CA, Luswata RK, Barrameda AJ, Le H, Muzazu S, Crowder R et al (2026) Diagnostic yield of tongue swab-compared to sputum-based molecular testing for tuberculosis in four high-burden countries. Clin Infect Dis. :ciag077\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePluslife (2025) MiniDock MTB Instructions for Use\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCohen JF, Korevaar DA, Altman DG, Bruns DE, Gatsonis CA, Hooft L et al (2016) STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. 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Lancet Global Health 12(7):e1184\u0026ndash;e91\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSteadman A, Kumar KM, Asege L, Kato-Maeda M, Mukwatamundu J, Shah K et al (2025) Diagnostic accuracy of swab-based molecular tests for tuberculosis using near-point-of-care platforms: a multi-country evaluation. EBioMedicine. ;121\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTheron G, Venter R, Smith L, Esmail A, Randall P, Sood V et al (2018) False-positive Xpert MTB/RIF results in retested patients with previous tuberculosis: frequency, profile, and prospective clinical outcomes. J Clin Microbiol 56(3):01696\u0026ndash;01617. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1128/jcm\u003c/span\u003e\u003cspan address=\"10.1128/jcm\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Stellenbosch University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"MiniDock MTB, sputum-scarce, tuberculosis, tongue swabs","lastPublishedDoi":"10.21203/rs.3.rs-6225528/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6225528/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eMiniDock MTB (Pluslife, China) is a near-point-of-care swab-based tuberculosis test. Most data are from people who can expectorate sputum. In 86 sputum-scarce symptomatic adults, retrospective testing detected 53% (95% CI 28–77) of tuberculosis; halving the amount missed if only sputum tests were available.\u003c/p\u003e","manuscriptTitle":"Diagnostic accuracy of Pluslife MiniDock MTB on tongue swabs in sputum scarce people with presumptive TB: a retrospective analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-23 13:13:41","doi":"10.21203/rs.3.rs-6225528/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"52fea32f-924c-4465-b6ad-bb9f01b8a9bc","owner":[],"postedDate":"March 23rd, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":64860518,"name":"Infectious Diseases"}],"tags":[],"updatedAt":"2026-03-23T13:13:41+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-23 13:13:41","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6225528","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6225528","identity":"rs-6225528","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}